Post-operative bacteria test strip spool and method

ABSTRACT

A method for testing body fluids is disclosed. The method includes providing a media-dispensing apparatus, placing at least the distal opening of the elongated tubular member adjacent body fluid (e.g., near a patient&#39;s abdomen) or adjacent a medical device such that a portion of the media strip contacts body fluid or the medical device, and advancing the media strip such that the portion of the media strip that contacted the body fluid or the medical device advances at least through the second lumen. Additionally, the step of cutting the media strip with a cutting instrument is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Divisional application of, claims thebenefits of and priority to U.S. patent application Ser. No. 11/388,176to Frank J. Viola, et al., filed on Mar. 24, 2006, which claims thebenefits of and priority to U.S. Provisional Application No. 60/687,107,filed on Jun. 3, 2005, the entire contents of each of which areincorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to body fluid testing devicesand methods, and more particularly, to a body fluid testing device andmethod that incorporates a post-operative test strip of material and amedia-dispensing apparatus.

2. Background of the Art

Infection is a serious complication of implantable and insertablemedical devices. The most common microorganisms causing thesecomplications are Staphylococcus epidermidis and Staphylococcus aureus,which account for about two-thirds of cases of contamination orinfection. Other gram-positive bacteria, gram-negative bacteria,viruses, and fungal microorganisms such as Candida, account for theremaining one-third of cases. Management of infected medical devices isvery expensive and in most instances requires the removal of theinfected device from the patient. Replacement medical devices must thenbe inserted or implanted in place of the contaminated medical device,which may require taking an X-ray to ensure proper insertion orimplantation of the medical device. Accordingly, removal and replacementof medical devices is costly to hospitals and patients.

In patients with indwelling medical devices who develop fever, thepossibility of device-related infection is considered. To accuratelydetermine if the medical device is the source of infection, the medicaldevice is typically removed and cultured to observe whether microbialactivity is present on the medical device. Accordingly, even if themedical device turns out not to be the source of infection, it hasalready been removed, and a new medical device must be put in place ofthe suspect medical device. It has been reported that as much as 85% ofindwelling central venous catheters that have been removed in suspicionof catheter-related infection yield sterile cultures. Thus, in as muchas 85% of the time that medical devices are removed from patients, themedical devices themselves are not causing the fever, and the removal ofthem, in hindsight, was not necessary.

It has been observed that in the majority of cases where microbialcontamination or infection of vascular catheters have been detected, theprimary cause was dermal microbial colonization at the insertion orimplantation site. The dermal microbial colonization migrated along themedical devices to colonize the medical devices at the interface betweenthe medical device and the insertion or implantation site. This findingsuggests that a prominent location to detect potentially pathogenicmicrobes would be at the medical device insertion or implantation site,and in some cases, on the external surface of the medical devices.

Infections are also attributed to leaks after suturing or staplingtissue, e.g., intestinal tissue. Intestinal contents have highconcentrations of bacteria, which, if leaked into the abdomen, may leadto an inflammation or an infection. With current technology, it isdifficult to detect the infection at an early stage when it is easiestto treat.

The acquisition and testing of body fluids is useful for many purposesand continues to grow in importance for use in medical diagnosis andtreatment, and in other diverse applications. In the medical field, itis desirable for operators to be able to perform such tests routinely,quickly and reproducibly. Testing can be performed on various bodyfluids, and for certain applications is particularly related to thetesting of blood and/or interstitial fluid. Such fluids can be testedfor a variety of characteristics of the fluid, or analytes contained inthe fluid, to identify a medical condition, determine therapeuticresponses, assess the progress of treatment, and the like.

Various methods and apparatus for testing body fluids have beendeveloped. These include inserting a syringe into a vein to withdraw ablood sample, making an incision in a patient's skin and collecting theblood in a container, and creating an incision and having patients urgefluid to the incision site by applying pressure to the area surroundingthe incision. Sampling devices may be used to analyze the sample for avariety of properties or components. Such devices include, for example,systems in which a tube or test strip is either located adjacent theincision site prior to forming the incision, or is moved to the incisionsite shortly after the incision has been formed. The test strips inthese systems include structure which react with the fluid to allow thesample to be analyzed. Such structure could allow for optical,electrochemical, and/or magnetic ways for analyzing the sampled fluid.One example of a testing device using a test media tape is disclosed inInternational Publication No. WO 2004/0005629 A1, the entire contents ofwhich are incorporated by reference herein.

SUMMARY

The present disclosure is directed to a media-dispensing apparatus fortesting body fluids. The apparatus includes a housing having a lowerportion and an upper portion that are separated by a separator, and anelongated tubular member having a distal opening adjacent a distal endthereof. A first lumen is disposed within the elongated tubular memberand extends from the lower portion of the housing to the distal opening.A second lumen is also disposed within the elongated tubular member andextends from the upper portion of the housing to the distal opening. Amedia strip (possibly a color changing medium which is able to detect oridentify an abnormality or an infection) is dispensable from the lowerportion of the housing (possibly around a central hub therein), throughthe first lumen, out of the distal opening of the elongated tubularmember, through the second lumen and into the upper portion of thehousing (and possibly through an aperture disposed through a portion ofthe upper portion).

In an embodiment of the present disclosure, a one-way passage valve isdisposed within at least one of the housing, the elongated tubularmember (e.g., the second lumen) and an interface therebetween. Theone-way passage valve allows the media strip to travel in a singledirection therethrough. In another disclosed embodiment, a seal isdisposed within at least one of the first lumen (e.g., adjacent a distalend thereof) and the second lumen. The seal is configured to allow themedia strip to pass therethrough and to limit the passage of bodyfluids.

In an embodiment of the present disclosure, at least a portion of adistal portion of the elongated tubular member is rounded or otherwisecurved. Further, in a disclosed embodiment, one lumen (e.g., the firstlumen) extends farther distally than the other lumen (e.g., the secondlumen).

In a disclosed embodiment, a cover is hingedly coupled to the hosing.The cover is movable between a first position where the cover is inproximity with the upper portion of the housing and at least a secondposition where the cover is spaced apart from the upper portion of thehousing. In an embodiment, a cutting instrument is disposed on a portionof at least one of the housing and the cover for cutting the mediastrip. In the embodiment where the cutting instrument is disposed on thecover, moving the cover from the second position to the first positioncuts the media strip.

The present disclosure also relates to a method for testing body fluids.The method includes providing a media-dispensing apparatus, as describedabove, placing at least the distal opening of the elongated tubularmember adjacent body fluid (e.g., near a patient's abdomen) or adjacenta medical device such that a portion of the media strip contacts bodyfluid or the medical device, and advancing the media strip such that theportion of the media strip that contacted the body fluid or the medicaldevice advances at least through the second lumen. Additionally, thestep of cutting the media strip with a cutting instrument is alsodisclosed.

In a disclosed method, a least a portion of the distal opening of theelongated tubular member remains adjacent body fluid or a medical deviceas the media strip is advanced.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure are described hereinbelow withreference to the drawings wherein:

FIG. 1 is a perspective view of a media-dispensing apparatus accordingto an embodiment of the present disclosure;

FIG. 2 is a perspective view of a housing and a cover of themedia-dispensing apparatus of FIG. 1;

FIG. 3 is a perspective assembly drawing of the housing and cover of themedia-dispensing apparatus of FIGS. 1 and 2, illustrated with aseparator, a knife and the cover separated from the housing;

FIG. 4 is an enlarged cross-sectional view of a distal portion of anembodiment of an elongated tubular member of the media-dispensingapparatus of FIGS. 1-3, illustrated with a media strip therein; and

FIG. 5 is an enlarged cross-sectional view of a distal portion of anembodiment of an elongated tubular member of the media-dispensingapparatus of FIGS. 1-3, illustrated with one lumen extending fartherdistally than the other lumen.

DETAILED DESCRIPTION

Embodiments of the presently disclosed media-dispensing apparatus aredescribed in detail with reference to the drawings wherein like numeralsdesignate identical or corresponding elements in each of the severalviews. As is common in the art, the term ‘proximal” refers to that partor component closer to the user or operator, e.g., surgeon, physician ornurse, while the term “distal” refers to that part or component fartheraway from the user.

FIGS. 1-3 illustrate a media-dispensing apparatus of the presentdisclosure which is generally indicated by reference numeral 100.Media-dispensing apparatus 100 is configured to dispense a media strip500 and includes a housing 200 and an elongated tubular member 300. Inthe embodiment illustrated in FIGS. 1-3, housing 200 includes a centralhub 210, a separator 220 and a cover 230. Elongated tubular member 300includes a proximal portion 302, a distal portion 304 and a distalopening 306. Elongated tubular member 300 also includes a first lumen310 and a second lumen 320 extending therethrough. Proximal portion 302of elongated tubular member 300 is operatively connected to housing 200.

More specifically, housing 200 includes a lower portion 202 where mediastrip 500 is initially placed and an upper portion 204 where media strip500 is directed to after media strip 500 is pulled through second lumen320 of elongated tubular member 300. Housing 200 may have a generalshape of a short cylinder, as shown in FIGS. 1-3 and may be closed onboth sides (housing 200 is illustrated with an open side for clarity).Housing 200 may also have any other suitable regular or irregular shape.Central hub 210 is shown disposed near the substantial center of housing200 and provides a surface for media strip 500 to wrap around. Inaddition, a bobbin or suitable alternative (not explicitly shown)wrapped with media strip 500 may be placed over central hub 210.

Separator 220 of housing 200 separates lower portion 202 of housing 200from upper portion 204 of housing 200. Lower portion 202 may be sealedand remain sterile, thus keeping media strip 500 free fromcontamination. Upper portion 204 of housing 200 does not remain sterileduring use since portions of media strip 500 that have contacted apatient or a medical device will pass therethrough. Thus, separator 220will keep potential contaminants within upper portion 204 and preventcontaminants from entering lower portion 202 of housing 200, thusmaintaining the sterility of lower portion 202.

A top piece 221 is included to cover upper portion 204 of housing 200.An aperture 222 (FIGS. 2 and 3) is disposed within top piece 221 andallows at least a portion of media strip 500 to exit housing 200, andmore specifically, to exit upper portion 204 of housing 200.

Cover 230 is disposed near upper portion 204 of housing 200 and may behingedly connected to housing 200. In such an embodiment, cover 230 ismovable between a first position where cover 230 is in proximity withupper portion 204 of housing 200 (FIG. 2) and at least a second positionwhere cover 230 is spaced apart from upper portion 204 of housing 200(FIG. 1). Cover 230 covers aperture 222 in top piece 221, thus reducingthe likelihood of outside contaminants entering housing 200.

Elongated tubular member 300 extends distally from housing 200 andincludes a first lumen 310 and a second lumen 320 extendingtherethrough. At proximal portion 302 of elongated tubular member 300,lumens 310, 320 are illustrated as being separated a distance from eachother, but it is envisioned that lumens 310, 320 may be closer togetheror farther apart than shown in the illustrated embodiment. First lumen310 extends from lower portion 202 of housing 200 and second lumen 320extends from upper portion 204 of housing 200. Distal portion 304 ofelongated tubular member 300 is dimensioned and configured to beinserted into a patient through an incision, a trocar and/or anintroducer (not explicitly shown). Further, in a disclosed embodiment,distal portion 304 of elongated tubular member 300 includes a roundedportion 305 (FIG. 4) adjacent first lumen 310 and/or adjacent secondlumen 320, which facilitates the travel of media strip 500. It isenvisioned that elongated tubular member 300 has a length in the rangeof about 10 inches to about 20 inches, and may be approximately equal to15 inches. Other suitable lengths of elongated tubular member 300 arealso contemplated. It is further envisioned that one lumen (e.g., firstlumen 310) extends farther than another lumen (e.g., second lumen 320),as shown in FIG. 5. In such a configuration, distal portion 304 ofelongated tubular member 300 would have a smaller diameter, thusenabling media-dispensing apparatus 100 to fit into a smaller incision.

It is envisioned that media-dispensing apparatus 100 includes a one-waypassage valve 250 (FIG. 1). One-way passage valve 250 prohibits mediastrip 500 from traveling in a non-desired direction. One-way passagevalve 250 may be disposed within housing 200, elongated tubular member300 and/or an interface (not explicitly shown) therebetween. In theembodiment where one-way passage valve 250 is located within secondlumen 320, one-way passage valve 250 precludes media strip 500 fromtraveling distally through second lumen 320 and/or proximally throughfirst lumen 310. Thus, the non-sterile portion of media strip 500 thathas already contacted a patient or medical device would be restrictedfrom moving backwards into sterile first lumen 310 and/or into sterilelower portion 202 of housing 200. If first lumen 310 becomescontaminated, it would lose its sterility, thus reducing the utility ofmedia-dispensing apparatus 100. One-way passage valve 250 may also bedisposed within or incorporated into aperture 222.

With reference to FIG. 4, a seal 260 is illustrated disposed withinfirst lumen 310 and adjacent a distal end 312 thereof. Within firstlumen 310, seal 260 is operably configured to allow the distal passageof media strip 500, while preventing or limiting the proximal passage ofother material (e.g., bacteria or body fluid from a surgical site). Itis envisioned for seal 260 to be disposed in other suitable portions ofmedia-dispensing apparatus 100.

A cutting instrument or knife 400 may be disposed near upper portion 204of housing 200 (FIG. 1). Knife 400 facilitates cutting a portion ofmedia strip 500. In the embodiment illustrated in FIG. 3, knife 400 isdisposed within cover 230. In such an embodiment, it can be appreciatedthat the action of moving cover 230 from its second position towards itsfirst position cuts a portion of media strip 500. It is furtherenvisioned for knife 400 to be recessed within cover 230, thus reducingthe likelihood that a person may be cut or that knife 400 may contactanother instrument.

In operation, media strip 500 is disposed at least partially withinmedia-dispensing apparatus 100. Media strip 500 wraps around central hub210 (or on a bobbin inserted onto central hub), extends distally throughfirst lumen 310, exits distal opening 306 of elongated tubular member300, extends proximally through second lumen 320, and extends into upperportion 204 of housing 200 and through aperture 222 of top piece 221. Totest a surgical site (e.g., body fluid, a medical device, etc.), aportion of elongated tubular member 300 of media-dispensing apparatus100 is inserted into a patient near a surgical site via an introducer,trocar, etc. Media strip 500 is then pulled through aperture 222. Mediastrip 500 is pulled far enough away from aperture 222 so that at least aportion of media strip 500 that contacted the surgical site passesthrough aperture 222. Knife 400 may then be used to cut media strip 500.Indicia (not explicitly shown), may be disposed on media strip 500and/or on media-dispensing apparatus 100 to aid a user in cutting mediastrip 500 at a proper location. Various testing methods may then beemployed to test media strip 500. It is envisioned that media-dispensingapparatus 100 is left in contact with a surgical site for an extendingperiod of time. Accordingly, a plurality of tests may be performedwithout removing media-dispensing apparatus 100 from the patient.

The method of the present disclosure includes providing media-dispensingapparatus 100 and performing the steps outlined above to test a patientand/or a surgical site for bacteria, contaminants, disease, etc. It isenvisioned to use media-dispensing apparatus 100 to test for bacteriafollowing an operative procedure, e.g., abdominal surgery.

It is envisioned that media strip 500 is comprised of litmus paper,another color-changing medium or any other suitable material to detectand/or identify abnormalities and/or infections. For example, the mediastrip 500 may be a protein polymer material that changes color after itcontacts bacteria.

It is further envisioned that media strip 500 includes distance markersand/or perforations (not shown). Such distance markers and/orperforations may be appropriately spaced to notify the user how farmedia strip 500 must be pulled from aperture 222 to ensure that at leasta portion of the media strip 500 that contacted the surgical site isremoved from housing 200.

It is further envisioned that a fixed or removable cap (not shown)covers lower portion 202 and/or upper portion 204 of housing 200. Such acap may fit over at least a majority of housing 200, thus reducing thelikelihood of external contamination.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, a bore may be disposedthrough a portion of housing (e.g., through central hub). Therefore, theabove description should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1. A method of testing body fluids, comprising the steps of: providing amedia-dispensing apparatus including a housing having a lower portionand an upper portion, an elongated tubular member extending distallyfrom the housing and having a distal opening adjacent a distal endthereof, a first lumen disposed within the elongated tubular memberextending from the lower portion of the housing to the distal opening, asecond lumen disposed within the elongated tubular member extending fromthe upper portion of the housing to the distal opening, and a mediastrip extending from the lower portion of the housing, through the firstlumen, out the distal opening of the elongated tubular member, throughthe second lumen and into the upper portion of the housing; placing atleast the distal opening of the elongated tubular member adjacent asurgical site such that a portion of the media strip contacts thesurgical site; and advancing the media strip such that the portion ofthe media strip that contacted the surgical site advances at leastthrough the second lumen.
 2. The method of testing body fluids accordingto claim 1, wherein the media-dispensing apparatus further includes acover hingedly coupled to the housing and a cutting instrument disposedon a portion of at least one of the housing and the cover, the coverbeing moveable between a first position where the cover is in proximitywith the upper portion of the housing and at least a second positionwhere the cover is spaced apart from the upper portion of the housing,such that moving the cover from the second position towards the firstposition cuts the media strip and wherein the method further includesthe step of cutting the media strip.
 3. The method of testing bodyfluids according to claim 1, wherein at least the distal opening of theelongated tubular member remains adjacent the surgical site as the mediastrip is advanced.
 4. The method of testing body fluids according toclaim 1, wherein at least a portion of the media-dispensing apparatus isinserted near a patient's abdomen.